Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS

This study has been terminated.

( Slow enrollment, protocol revisions in 2006, decreased sample size from 850 to 100, 91 randomized. No unexpected safety issues. )

First Received: September 13, 2005 Last Updated: November 7, 2008 History of Changes

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00202995

Purpose

Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®

Condition	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: Glatiramer Acetate Drug: Betaseron Drug: Rebif	Phase IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta-1b Interferon beta 1a Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

The primary objective of the study is to compare the total number of confirmed relapses experienced by the patients randomized to continue their current high-dose of IFN therapy (Betaseron® 250 µg or Rebif® 44 µg) to that observed in patients randomiz [ Designated as safety issue: No ]

Enrollment:	91
Study Start Date:	July 2004
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Glatiramer Acetate 20 mg s.c. daily	Drug: Glatiramer Acetate 20 mg s.c. daily
2: Active Comparator Betaseron 250 ug every other day or Rebif 44 ug 3 times a week	Drug: Betaseron 250 mg every other day Drug: Rebif 44 ug 3 times a week

Detailed Description:

This is a multi-center, randomized, single blind, parallel group study to compare the efficacy, tolerability and safety of injectable Copaxone®(GA) to that of high dose interferon (beta 1a or 1b) in relapsing MS patients.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria
Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry
Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required.
Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive
Patients must be between the ages of 18 and 50 years inclusive
Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or IUD with spermicide), or partner's vasectomy
Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit
Patients must be relapse-free and off corticosteroids between the screening and baseline visits
Patients must be willing and able to give written informed consent

Exclusion Criteria:

Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry
Previous treatment with glatiramer acetate (injectable)
Previous treatment with immunomodulators (except IFNβ), immunosuppressive agents, IVIG, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years
Previous total body irradiation or total lymphoid irradiation
Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry
Pregnancy or breastfeeding
Life-threatening or other clinically significant disease
Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse
A known sensitivity to gadolinium (gadolinium acid)
A known history of sensitivity to mannitol
Inability to successfully undergo MRI scanning

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202995

Show 37 Study Locations

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

Helene Brooks

Teva Pharmaceutical Industries

More Information

No publications provided

Responsible Party:	Teva Neuroscience ( Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations )
Study ID Numbers:	9013
Study First Received:	September 13, 2005
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00202995 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Interferons
Adjuvants, Immunologic
Disease Progression
Interferon-beta
Sclerosis

Immunosuppressive Agents
Multiple Sclerosis, Relapsing-Remitting
Copolymer 1
Multiple Sclerosis
Interferon beta 1a
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Sclerosis
Immunosuppressive Agents

Multiple Sclerosis, Relapsing-Remitting
Pharmacologic Actions
Copolymer 1
Multiple Sclerosis
Pathologic Processes
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009